SABER

Description of Event or Problem

AS REPORTED, AN 8F 90 CM MULTIPURPOSE (MPA) VISTA BRITE TIP GUIDING CATHETER WAS USED TO GUIDE A NON-CORDIS LONG SHEATH ACROSS TO THE LEFT ILIAC ARTERY TO ESTABLISH ACCESS; HOWEVER, IT WAS LATER FOUND THAT THE DISTAL BRITE TIP HAD DETACHED INTO THE PROFUNDA FEMORIS ARTERY. THE SEPARATED TIP WAS SUCCESSFULLY RETRIEVED USING A NON-CORDIS PROTECTION UMBRELLA. A 5 MM X 25 CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS THEN USED TO DILATE THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER DEFLATING AND WITHDRAWING THE SABER PTA BALLOON CATHETER, AN A 5F 100 CM VERTEBRAL (VERT) TEMPO DIAGNOSTIC CATHETER WAS REINSERTED FOR ANGIOGRAPHY; HOWEVER, OBVIOUS RESISTANCE WAS FOUND AND IT WAS OBSERVED THAT THE DISTAL END OF THE WITHDRAWN SABER PTA BALLOON HAD SEPARATED AND REMAINED IN THE SFA. THE FRACTURED PORTION OF THE BALLOON BODY WAS SUBSEQUENTLY RETRIEVED USING AN UNKNOWN SNARING DEVICE. AN IMAGE WAS PROVIDED OF THREE DEVICES. IN THE IMAGE, THE RESIDUAL SABER PTA BALLOON FRAGMENT IS SEEN ATTACHED TO AN UNKNOWN SNARING DEVICE. TO THE RIGHT OF THE SABER PTA FRAGMENT, THE 8F MPA VISTA BRITE TIP GUIDING CATHETER IS SEEN WITH A MISSING BRITE TIP, AND AN UNKNOWN, UNDAMAGED GUIDING CATHETER USED DURING A SEPARATE PROCEDURE IS SEEN TO THE RIGHT OF THE VISTA BRITE TIP GUIDING CATHETER FOR COMPARISON. THE INTENDED PROCEDURE WAS A LOWER LIMB ARTERIAL INTERVENTION. THE TARGET VESSEL WAS THE LEFT SFA AND THE PATIENT HAD A PREVIOUSLY PLACED STENT AT THE OPENING OF THE LEFT COMMON ILIAC ARTERY. THEREFORE, A RETROGRADE PUNCTURE OF THE RIGHT FEMORAL ARTERY WAS USED FOR ACCESS. THE TARGET VESSEL WAS MILDLY CALCIFIED, MILDLY TORTUOUS, AND HAD 60% STENOSIS. THE FACILITY USES ULTRAVIOLET (UV) ROOM STERILIZATION, BUT THE DEVICES WERE NOT EXPOSED TO UV LIGHT DURING STORAGE, AND OZONE STERILIZATION WAS NOT USED. FOR THE 8F MPA VISTA BRITE TIP CATHETER, THE DEVICE WAS STORED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTY REMOVING IT FROM THE PACKAGING, NO ANOMALIES NOTED PRIOR TO USE, NO RESISTANCE OR FRICTION DURING ADVANCEMENT, NO ACUTE BEND DURING THE PROCEDURE, NO ENTRAPMENT IN THE PATIENT, AND NO DIFFICULTY DURING WITHDRAWAL. THE DISTAL TIP SEPARATION WAS NOT OBSERVED WHILE THE DEVICE WAS IN THE PATIENT, BUT IT WAS OBSERVED AFTER REMOVAL, AND NO REPLACEMENT GUIDE CATHETER WAS USED. FOR THE SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE WAS STORED AND PREPARED PER THE IFU, WITH NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS OR PROTECTIVE BALLOON COVER, NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION, THE CONTRAST-TO-SALINE RATIO WAS 50:50, THE DEVICE WAS INFLATED TO 18 ATMOSPHERES (ATM), NO LOSS OF PRESSURE WAS OBSERVED DURING INFLATION, THE BALLOON WAS FULLY DEFLATED BEFORE WITHDRAWAL, AND THERE WAS NO DIFFICULTY WITHDRAWING IT FROM THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

PLEASE NOTE THAT THE LOT NUMBER IS UNKNOWN. A DEVICE IMAGE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.